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Senior Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, Usa)

4-6 years
$121,000 - 159,000
10 March 21, 2025
Job Description
Job Type: Full Time Education: PhD/PharmD/M.Sc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Manager, Medical Writing - Innovative Medicine R&D - Teva Pharmaceuticals - 59605

Date: March 7, 2025
Location: Remote, East Coast, USA (Macon, New Hampshire, 10903)

Who we are:
Teva Pharmaceuticals is committed to making good health more affordable and accessible in nearly 60 countries, impacting over 200 million lives daily. As the world's leading manufacturer of generic medicines and a producer of many WHO-listed essential medicines, Teva continues to innovate and make a positive difference.

The opportunity:
As a Senior Manager in Global Regulatory Medical Writing, you will write and edit clinical regulatory documents, including submission summaries and other complex materials essential for drug development and product registrations. You will provide intermediate-level oversight, guidance, and resource management to ensure the effective production of high-quality clinical research documentation.

How you’ll spend your day:

  • Product and Program-Level Leadership: Manage key regulatory documents at the product and program level.

  • Team and Vendor Oversight: Potentially oversee direct reports, contingent workers, and/or vendors, while offering training and resource management support.

  • Strategic Supervision: Provide supervision, leadership, and planning for clinical regulatory document development.

  • Regulatory Document Writing: Write and edit clinical regulatory documents, ensuring accuracy, completeness, and adherence to regulatory guidelines and editorial standards.

  • Content Consistency: Ensure clarity, consistency, and proper scientific messaging in line with best practices.

  • Template Management: Contribute to the preparation and revision of document templates to enhance efficiency and quality.

Your experience and qualifications:

Education:

  • PhD or PharmD in Life Sciences (or related field) with a minimum of 4 years of experience OR

  • Master’s degree in Life Sciences (or related field) with at least 6 years of experience.

Preferred Experience:

  • 4-6 years of experience in regulatory medical writing.

  • Proficiency in Microsoft Word and experience with document templates and electronic formats.

  • Strong knowledge of global regulations and guidelines for document submissions, therapeutic areas, statistical concepts, and product development.

  • Advanced English language proficiency, both written and spoken.

Compensation:

  • Annual starting salary between $121,000 - $159,000.

  • Factors affecting pay include location, skills, education, experience, and other qualifications.

  • Position may be eligible for bonuses based on experience and performance criteria.

Role location:

  • US-Based Remote (US Eastern time zone preferred)

  • Note: No relocation assistance or work visa sponsorship available.

Benefits:

  • Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on day one.

  • Retirement Savings: 401(k) with 6% employer match and an annual 3.75% Defined Contribution.

  • Time Off: Paid Time Off, including vacation, sick/safe time, 13 paid holidays, and 3 floating holidays.

  • Life and Disability Protection: Company-paid Life and Disability insurance.

  • Additional Benefits: Employee Assistance Program, Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Paid Parental Leave, and more.

Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is committed to equal opportunity in employment regardless of legally protected statuses. We are dedicated to fostering a diverse and inclusive workplace for all.